Skills

SYNOPSIS

❖ Overall 12 years experience in Pharma Industry.

❖ Currently associate with Dr.Reddys Laboratories Ltd, Duvvada

SEZ, Visakhapatnam (A.P.) as Asst.QA Manager (R1B – Role

Band) in \"Quality Assurance Department\" (QMS Section).

❖ Successfully faced regulatory audits of USFDA, TGA, MCC, ANVISA,

EMA, MHRA and Ministry of Health (like Germany, Tanzania,

Malaysia, Zimbabwe, Yemen, Turkey).

❖ Successfully faced non regulatory audits of IDMA (Indian Drug

Manufacturing Association), ISO 13485:2003, ISO 9001:2008.

❖ Strong CAPA tracking, timely compliance of non conformance,

analytical, problem solving and organizational abilities. Possess a

flexible and detail oriented attitude.

❖ Involved in Out of Specification / Out of Trend Phase-II Investigation.

❖ Investigate the Field Alert Report (FAR) related to repetitive market

complaints, stability failure, etc.

❖ Ensuring the adherence to local and other regulatory agencies

approving the plant.

❖ Involved in Self Inspection activity to inspect the plant as per current

regulatory norms.

❖ Presented 10th Paper Presentation in National Conferences during

the period of pharma graduation.

HONOR AWARDS

❖ Received \"Champion of the Week\" award in Dr.Reddy\'s Laboratories

Ltd for Year 2019.

❖ Received \"Best Performer of the Month\" in Cipla Ltd, Goa for the

Year 2017.

❖ Received \"Best Student of the Year Award\" in academic year of

pharmacy Graduation.

PREFESSIONAL SOFTWARE SKILL

Completely familiar with SAP, SAP FIORI, Track Wise, Cipdox, Dochub,

Pilgrim, and RA Documentum.

COMPUTER SKILL

Completely familiar with MS office use and MS-CIT Computer Course, Good

knowledge of Internet along with passed English Typewriting 30 and 40

W.P.M.

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